NCM 108 Bioethics - Finals Notes

III. BIOETHICS AND RESEARCH and it was conducted at the Palace of Justice in
A. Principles of Ethics Research Nuremberg, Bavaria, Germany.  The trial was
Definitions of Terms conducted here because this was one of the few
Biology- The word biology is derived from the Greek largely undamaged buildings that remained
words /bios/ meaning /life/ and /logos/ meaning /study/ intact from extensive Allied bombing during the
and is defined as the science of life and living organisms. war.  It is also said to have been symbolically
Ethics- moral principles that govern a person's behavior chosen because it was the ceremonial birthplace
or the conducting of an activity. of the Nazi Party.  Of the 23 defendants, 16 were
Research- the systematic investigation into and study of found guilty, of which seven received death
materials and sources in order to establish facts and sentences and nine received prison sentences
reach new conclusions. ranging from 10 years to life imprisonment. The
Clinical Research- Research in which people, or data or other 7 defendants were acquitted. 
samples of tissue from people, are studied to understand The verdict also resulted in the creation of
health and disease. Clinical research helps find new and the Nuremberg Code, a set of ten ethical principles for
better ways to detect, diagnose, treat, and prevent human experimentation. 
disease.
What Are the Nuremberg Code's Ethical Guidelines
Nuremberg Code for Research?
o The Nuremberg Code is one of the most o The Nuremberg Code aimed to protect human
influential documents in the history of clinical subjects from enduring the kind of cruelty
research.   and exploitation the prisoners endured at concentration
o Created more than 70 years ago following the camps. The 10 elements of the code are: 
notorious World War II experiments, this written 1. Voluntary consent is essential
document established 10 ethical principles for 2. The results of any experiment must be for the
protecting human subjects.  greater good of society
o We'll take a closer look at its origins, its 3. Human experiments should be based on
guidelines and its enduring impact.  previous animal experimentation
What Is the Nuremberg Code? 4. Experiments should be conducted by avoiding
o When World War II , ended in 1945, the physical/mental suffering and injury
victorious Allied powers enacted the 5. No experiments should be conducted if it is
International Military Tribunal on November believed to cause death/disability
19th, 1945.  As part of the Tribunal, a series of 6. The risks should never exceed the benefits
trials were held against major war criminals and 7. Adequate facilities should be used to protect
Nazi sympathizers holding leadership positions subjects
in political, military, and economic areas.  The 8. Experiments should be conducted only by
first trial conducted under the Nuremberg qualified scientists
Military Tribunals in 1947 became known as 9. Subjects should be able to end their participation
The Doctors’ Trial, in which 23 physicians from at any time
the German Nazi Party were tried for crimes 10. The scientist in charge must be prepared to
against humanity for the atrocious experiments terminate the experiment when injury, disability,
they carried out on unwilling prisoners of war.  or death is likely to occur
Many of the grotesque medical experiments took
place at the Auschwitz concentration camp, Declaration of Helsinki
where Jewish prisoners were tattooed with • Ethical Principles for Medical Research
dehumanizing numbers onto their arms; numbers Involving Human Subjects
that would later be used to identify their bodies • Developed by the World Medical Association
after death. (WMA), as a set of ethical principles for the
o The Doctors’ Trial is officially titled “The medical community regarding human
United States of America v. Karl Brandt, et al.,”
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NCM 108 Bioethics - Finals Notes
experimentation, and is widely regarded as the • The Belmont Report was written by the
cornerstone document of human research ethics. National Commission for the Protection of
General Principles Human Subjects of Biomedical and
• It is the duty of the physician to promote and Behavioral Research.
safeguard the health of the people. The
physician’s knowledge and conscience are
dedicated to the fulfillment of duty. National Commission for the Protection of
• The primary purpose of medical research Human Subjects of Biomedical and Behavioral Research
involving human subjects is to understand the • Carrying out its charge, the Commission
causes, development and effects of diseases and prepared the Belmont Report in 1979.
improve preventive, diagnostic and therapeutic • The Belmont Report is a statement of basic
interventions (methods, procedures and ethical principles and guidelines that provide “an
treatments.) analytical framework to guide the resolution of
• Medical research is subject to ethical standards the ethical problems arising from research with
that promote and ensure respect for all human human subjects.”
subjects and protect their health and rights. • The framework of the Belmont Report is
• Appropriate caution must be exercised in the presented in three discussion topics: boundaries
conduct of medical research that may harm the between practice and research; basic ethical
environment. principles, and applications.
• The design and performance of each research Boundaries between Practice and Research
study involving human subjects must be clearly • The distinction between practice and research is
described in a research protocol. blurred; often because they occur together.
• It is the duty of physicians who are involved in • The IRB must ensure that the researcher (and the
medical research to protect life, health, dignity, participant) distinguishes practice from research
integrity, right to self-determination, privacy, in both social science and biomedical research
and confidentiality of personal information of • Minimize the potential for therapeutic
research subjects. misconception – when one believes the purpose
• Medical research should be conducted in a of clinical research is to treat rather then to gain
manner that minimizes possible harm to the knowledge
environment. Basic Ethical Principles
• The research protocol must be submitted for • Respect for Persons
consideration, comment, guidance and approval • Treat individuals as autonomous
to a research ethics committee before the study persons; allow individuals to choose for
begins. themselves
• Medical research is subject to ethical standards • Persons with limited autonomy need
that promote and ensure respect for all human additional protection, even to the point
subjects and protect their health and rights. of excluding them from activities that
• Medical research involving human subjects must may harm them. The extent of
be conducted only by individuals with the protection should depend upon the risk
appropriate scientific training and qualifications. of harm, and the likelihood of benefit.
• The judgment that any individual lacks
Belmont Report autonomy should be periodically re-
• The Belmont Report was written in response to evaluated, and will vary across
the infamous Tuskegee Syphilis Study, in situations.
which African Americans with syphilis were
lied to and denied treatment for more than 40 • Individuals should be treated as autonomous
years. Many people died as a result, infected agents
others with the disease, and passed congenital • Individuals with diminished autonomy are
syphilis onto their children. entitled to protections
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NCM 108 Bioethics - Finals Notes
• Beneficence The issue arises particularly where EBP enters
• Obligations of beneficence affect both protocols and guidelines which are supposed to
the researcher and society – be used as the primary decision-making aid for
• investigators are required to give practitioner.
forethought on maximization of benefits • Two problems:
and reduction of risk that may be • Patients lose choice
involved in the research • Practitioners lose choice
• society should recognize the longer term 3) "Testable by RCT" is not the same as "most effective"
benefits and risk that may result from EBP puts highest value on evidence from randomised
the improvement of knowledge, and controlled trials (RCTs). However, this can produce
from the development of novel medical, unethical results (Zwitter 2001; Vos et al. 2004; Vineis
psychological, and social processes and 2004; Rysavy 2013).
procedures 4) Decisions based on EBP can be unjust
• Those funding a health system would seem well
• Do not harm advised only to fund interventions for which
• Maximum possible benefits, and minimize there is evidence.(Ashcroft & ter Meulen 2004;
potential harms Vos et al. 2004; Kerridge et al. 1998; Jansen
• Justice 1997; Hughes 1996; Hope 1995). This can result
• Treat people fairly in what seem to be unjust decisions of various
• Do not exploit those who are readily types. In the first place, rare conditions are
available or malleable difficult to test via RCTs as there are insufficient
• Fair distribution of the risks and the cases to run a trial likely to reach statistical
benefits of research based upon the significance. Patients with these conditions
problem/issue under investigation might find that promising but insufficiently
• Fair distribution of burdens and benefits of tested treatments are unfunded. Other conditions
research are common but are such that it is difficult to
Applications of the General Principles find funding to run expensive RCTs of their
• Consideration of the three general principles in treatment.
the conduct of research lead to the consideration o Nurses must address the ethico-moral principles
of: of justice, beneficence, nonmaleficence,
• Informed Consent process accountability, fidelity, autonomy, and veracity.
• Risk/Benefits assessment o Justice is synonymous with fairness. Nurses
• Selection of research participants must be fair when distributing care, such as
among patients in a group of patients that they
B. Ethical issues in Evidenced Based Practice are caring for. Care must be distributed fairly,
1. Some types of knowledge are not included in EBP justly, and equitably among a group of patients.
• EBP downgrades or discounts types of o Beneficence is doing what is good and right for
knowledge that are used by practitioners and the patient.
which are important for good practice; these o As stated in the historical Hippocratic Oath,
include experience, intuition and anecdote nonmaleficence means doing no harm.
(Barker 2000; Bax 2008; Milton 2007; Tonelli Intentional or unintentional harm can occur.
1998). o Accepting responsibility for one's own actions is
2) EBP runs counter to patient-centered care what accountability entails. Nurses are
• The type of knowledge that is discounted by accountable for their nursing care and other
EBP is often specific to case or circumstance. actions. They must accept all of the professional
By insisting that all practice is based on up to- and personal consequences that can occur as the
date research evidence where it is available, result of their actions.
patient-centred care, which requires case-
specific knowledge and intuition, is undermined.
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NCM 108 Bioethics - Finals Notes
o Fidelity is keeping one's promises. The nurse the presentation of complex information in
must be faithful and true to their professional useful forms.
promises and responsibilities by providing high o Performance measurement and payment are
quality, safe care in a competent manner. increasingly linked to goals established by
o Autonomy and patient self-determination are practice guidelines. The best guidelines are
upheld when the nurse accepts the client as a based on systematic reviews and patient-oriented
unique person who has the innate right to have evidence, use an evidence-rating system such as
their own opinions, perspectives, values and the Strength of Recommendation Taxonomy,
beliefs. Nurses encourage patients to make their and are prospectively validated. The guidelines
own decision without any judgments or coercion also should have a transparent development
from the nurse. The patient has the right to reject process, identify potential conflicts of interest,
or accept all treatments. and offer flexibility in various clinical situations.
o Veracity is being completely truthful with
patients; nurses must not withhold the whole Attributes of Good Practice Guidelines
truth from clients even when it may lead to
patient distress.
o The most commonly occurring ethical issues and • Comprehensive, systematic evidence search with
concerns in healthcare include the allocation of end date noted
scarce resources and end of life issues. • Evidence linked directly to recommendations via
strength of recommendation grading system*
C. Ethico-Moral Obligations • Recommendations based on patient-oriented
1. Introduction of Good Practice Guidelines rather than disease-oriented outcomes
• Transparent guideline development process
o The Good Practice Guidelines (GPG) 2018 • Potential conflicts of interest identified and
Edition is the definitive guide for business addressed
continuity and resilience professionals. The • Prospectively validated (i.e., guideline use has
GPG Is used as an information source for been shown to improve patient-oriented
individuals and organizations seeking an outcomes)
understanding of business continuity as part of • Recommendations offer flexibility in various
their awareness raising campaigns and training clinical situations
schedules. The GPG takes a collaborative • The identification of attributes of practice
approach to business continuity, ensuring guidelines rests on four principles. These
organizations and individuals understand how to principles call for:
work with related management disciplines to • Clarity in the definition of each attribute;
successfully implement their business continuity • Compatibility of each attribute and its
solutions. definition with professional usage;
o The Good Practice Guidelines draw on the • Clear rationales or justifications for the
knowledge of practitioners from all over the selection of each attribute; and
world as well as information within International • Sensitivity to practical issues in using the
Standards. As a result, the GPG is globally attributes to assess actual sets of practice
recognized as the go-to publication for good guidelines ("accessibility
practice.
o Developing practice guidelines that enlighten IV. GUIDELINES AND PROTOCOL IN
practitioners and patients is an exceptionally DOCUMENT AND HEALTH CARE RECORDS
challenging task. It requires diverse skills
ranging from the analysis of scientific evidence
to the management of group decision-making to V. ETHICAL CONSIDERATION IN LEADERSHIP
AND MANAGEMENT

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NCM 108 Bioethics - Finals Notes
Ethical Dilemmas
 Occur when a problem exists between ethical
principles
 Deciding in favor of one principle usually
violates another
 Both sides have “goodness” and “badness”
associated with them

A. Moral Decision Making

1. Principle of Moral Discernment

2. Principle of Well-Formed Conscience

3. Strategies of Moral Decision Making (Ethical

Dilemma)

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NCM 108 Bioethics - Finals Notes
VI. ETHICAL ISSUES RELATED TO  Personal information controller refers to a person or
TECHNOLOGY IN THE DELIVERY OF HEALTH organization who controls the collection, holding,
CARE processing or use of personal information, including
a person or organization who instructs another
DATA PROTECTION AND SECURITY person or organization to collect, hold, process, use,
Data security is any type of preventative measure that transfer or disclose personal information on his or
helps secure and protect data. The objective of data her behalf.
security for healthcare operations is to develop an  Personal information processor refers to any natural
effective and efficient plan to ensure their data and or juridical person qualified to act as such under this
patient data are as secure as possible. Act to whom a personal information controller may
outsource the processing of personal data pertaining
Today, nurses, doctors, and other healthcare to a data subject.
professionals rely on technologies, such as computers  Privileged information refers to any and all forms of
and tablets, to access, update, and record patient data. data which under the Rules of Court and other
pertinent laws constitute privileged communication.
Data may also be shared between multiple facilities and
healthcare providers. As such, better healthcare data BENEFITS & CHALLENGES OF TECHNOLOGY
security solutions are needed to help reduce the risks of • Digital technology has become an integral part
malicious data attacks or technical failure. of healthcare and is all set to revolutionize the
practice of medicine. Digital technology has
SECTION 1. Short Title. This Act shall be known as greatly improved operational efficiency with
the “Data Privacy Act of 2012”. respect to standards of medical care. The
transformation has significantly enhanced the
SECTION 2- Declaration of Policy overall experience of both healthcare
It is the policy of the State to protect the fundamental professionals and patients.
human right of privacy, of communication while • IMPROVE ACCESS TO MEDICAL
ensuring free flow of information to promote INFORMATION & DATA
innovation and growth. • BIG DATA
The State recognizes the vital role of information and • IMPROVE LINES OF COMMUNICATION
communications technology in nation-building and its • ELECTRONIC HEALTH RECORDS
inherent obligation to ensure that personal information • ONLINE EDUCATION
in information and communications systems in the • HEALTH APPS
government and in the private sector are secured and
protected. CURRENT TECHNOLOGY: ISSUES AND
DILEMMA
SECTION 3. Definition of Terms Privacy and confidentiality
Consent of the data subject refers to any freely given,  medical information is suddenly available on
specific, informed indication of will, whereby the data multiple devices, there is an increased risk of
subject agrees to the collection and processing of security problems.
personal information about and/or relating to him or her. Security Breaches
 threaten patient privacy when confidential health
 Personal information refers to any information information is made available to others without
whether recorded in a material form or not, from the individual's consent or authorization.
which the identity of an individual is apparent or can Security measures such as firewalls, antivirus
be reasonably and directly ascertained by the entity software, and intrusion detection software must
holding the information, or when put together with be included to protect data integrity.
other information would directly and certainly Misinformation
identify an individual.  false information that is spread, regardless of
intent to mislead.
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NCM 108 Bioethics - Finals Notes
Data Inaccuracies
 concerns have been raised about the accuracy
and reliability of data entered into the electronic
record.
Access to Technology
 some client groups may not have access to the
necessary technology. Practitioners and patients
alike, may not have the skills to use these
platforms. Both parties need to be able to use
technology and quickly troubleshoot issues.

Overall, digital technology has transformed healthcare.

And this transformation is expected to continue in the
years to come. Artificial Intelligence, machine learning,
deep learning, blockchain, healthcare mobile apps,
wearables and many other such advancements will
change the future of healthcare. As long as healthcare
organizations and healthcare professionals keep their
minds open and create the required infrastructure and
systems, there is no saying how far digital technology
can go in healthcare.

VII. CONTINUING EDUCATION PROGRAMS ON

ETHICO-MORAL PRACTICE IN NURSING
A. Lobbying/ Advocating for Ethical
Issues Related to Health Care
B. Code of Ethics for Nurses
1. International Code of Ethics
2. Code of Ethics for Filipino Nurses
 Registered Nurses and
People
 Registered Nurses and
Practice
 Registered Nurses and Co-
Workers
 Registered Nurses and
Society and Environment
 Registered Nurses and the
Profession
C. Philippine Nursing Act 2002 RA 9173

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